MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Stroke/CVA (1770); Foreign Body In Patient (2687)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while performing a mechanical thrombectomy on an emergent stroke patient, the tip of the microcatheter (subject device) fractured off from the catheter into the patient's head.The tip of the catheter (subject device) was not in a retrievable disposition.The catheter (subject device) was pulled off of the sterile field.No additional information available.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Additional Manufacturer Narrative
B5 executive summary - updated.C2/d10concomitant products grid - added.E1 - initial reporter first name - updated.E1 initial reporter last name ¿ updated.E1 initial reporter phone ¿ updated.E3 health professional occupation ¿ updated.F10 / h6 clinical signs code grid - health effect - clinical code - updated.F10 / h6 health impact code grid - health effect - impact code - updated.
Event or Problem Description
It was reported that while performing a mechanical thrombectomy on an emergent stroke patient, the tip of the microcatheter (subject device) fractured off from the catheter into the patient's head.The tip of the catheter (subject device) was not in a retrievable disposition.The catheter (subject device) was pulled off of the sterile field.No additional information available.Update: additional information received on 28-jun-2023 stated that the catheter tip was broken/fractured during use.The catheter tip (subject device) was not in a retrievable disposition which caused meticulous stridal stroke.Patient passed away two days post procedure due to family withdrew care and stroke (patient¿s initial pre- procedure/index condition was stroke).Then, additional information received on 06-jul-2023 stated that the subject device is not responsible for the death of the patient.No additional information available.
Additional Manufacturer Narrative
F10 / h6 health impact code grid - health effect - impact code - updated.
Event or Problem Description
It was reported that while performing a mechanical thrombectomy on an emergent stroke patient, the tip of the microcatheter (subject device) fractured off from the catheter into the patient's head.The tip of the catheter (subject device) was not in a retrievable disposition.The catheter (subject device) was pulled off of the sterile field.No additional information available.Update: additional information received on 28-jun-2023 stated that the catheter tip was broken/fractured during use.The catheter tip (subject device) was not in a retrievable disposition which caused meticulous stridal stroke.Patient passed away two days post procedure due to family withdrew care and stroke (patient¿s initial pre- procedure/index condition was stroke).Then, additional information received on 06-jul-2023 stated that the subject device is not responsible for the death of the patient.No additional information available.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information received indicated while performing a mechanical thrombectomy on an emergent stroke patient, the tip of the microcatheter fractured off from the catheter into the patient's head.The catheter tip was not in a retrievable disposition.The catheter tip (subject device) detached was not in a retrievable disposition which caused meticulous stridal stroke.There was medical intervention but not due to catheter breaking, only due to patient stroke condition.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation.While there are a number of potential causes for the reported 'catheter tip broken/fractured during use' and 'un-retrieved device fragment', because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke¿ as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labelling and/or risk documentation files.
Event or Problem Description
It was reported that while performing a mechanical thrombectomy on an emergent stroke patient, the tip of the microcatheter (subject device) fractured off from the catheter into the patient's head.The tip of the catheter (subject device) was not in a retrievable disposition.The catheter (subject device) was pulled off of the sterile field.No additional information available.Update: additional information received on 28-jun-2023 stated that the catheter tip was broken/fractured during use.The catheter tip (subject device) was not in a retrievable disposition which caused meticulous stridal stroke.Patient passed away two days post procedure due to family withdrew care and stroke (patient¿s initial pre- procedure/index condition was stroke).Then, additional information received on 06-jul-2023 stated that the subject device is not responsible for the death of the patient.No additional information available.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17160055
• Report Number: 3008881809-2023-00309
• Device Sequence Number: 17540410
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Model Number: M003XT2750810
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 24174468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023; 08/28/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/07/2023; 07/14/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOLITAIRE STENT (NON-STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female